Automated Therapy System and Method

ABSTRACT

An automated therapy system having an infusion catheter; a sensor adapted to sense a patient parameter; and a controller communicating with the sensor and programmed to control flow output from the infusion catheter into a patient based on the patient parameter without removing fluid from the patient. The invention also includes a method of controlling infusion of a fluid to a patient. The method includes the following steps: monitoring a patient parameter with a sensor to generate a sensor signal; providing the sensor signal to a controller; and adjusting fluid flow to the patient based on the sensor signal without removing fluid from the patient.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.13/354,210, filed Jan. 19, 2012, now U.S. Pat. No. 8,480,648; whichapplication is a continuation of U.S. application Ser. No. 12/098,365,filed Apr. 4, 2008, now U.S. Pat. No. 8,100,880; which applicationclaims the benefit of U.S. Provisional Patent Application No.60/921,974, filed Apr. 5, 2007 to Burnett, entitled “Safety AccessDevice, Fluid Output Monitor & Peritoneal Organ Preservation”, alldisclosures of which are incorporated by reference herein in theirentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference to the same extent as if eachindividual publication or patent application was specifically andindividually indicated to be incorporated by reference.

BACKGROUND OF THE INVENTION

Fluids and other substances are infused into patients for a variety ofreasons. For example, fluids may be given to a patient intravenously tohydrate the patient or to control overall blood volume.

It is often important to control infusion of fluid into patients inorder to optimize the therapy being provided. Monitoring of patientparameters can consume precious health care time and resources, however.Fluid infusion into patients is therefore not always optimized.

Mantle US 2006/0161107 describes a system that extracts fluid from abody cavity, processes the fluid and then recirculates fluid back intothe cavity. Mantle does not describe infusion of a fluid into a patientwithout extraction of the fluid from the patient, however. In addition,the parameters on which the Mantle system is controlled are limited.

SUMMARY OF THE INVENTION

One aspect of the invention provides an automated therapy system havingan infusion catheter; a sensor adapted to sense a patient parameter; anda controller communicating with the sensor and programmed to controlflow output from the infusion catheter into a patient based on thepatient parameter without removing fluid from the patient. In someembodiments, the sensor may be incorporated into the catheter, and inother embodiments, the sensor may be separate from the catheter. Thesensor may be, e.g., an ECG sensor; an EEG sensor; a pulse oximetrysensor; a blood pressure sensor; a cardiac output sensor; athermodilution cardiac output sensor; a cardiac stroke volume sensor; aheart rate sensor; a blood flow sensor; a pH sensor; a blood pO₂ sensor;an intracranial pressure sensor; and/or a solute sensor.

In embodiments of the invention, the catheter may be a peripheral venouscatheter; a central venous catheter; an arterial catheter; or aperitoneal catheter (possibly incorporating an intraperitoneal pressuresensor).

Another aspect of the invention provides a method of controllinginfusion of a fluid to a patient. The method includes the followingsteps: monitoring a patient parameter with a sensor to generate a sensorsignal; providing the sensor signal to a controller; and adjusting fluidflow to the patient based on the sensor signal without removing fluidfrom the patient. In some embodiments, the method includes the step ofmonitoring cardiac output with the sensor and, possibly, adjusting fluidflow to the patient based on cardiac output monitored by the sensor. Inembodiments of the invention, the patient parameter includes anelectrocardiogram; an electroencephalogram; blood oxygen saturation;blood pressure; cardiac output; cardiac stroke volume; heart rate; bloodflow; total circulating blood volume; whole body oxygen consumption; pH;blood pO₂; osmolarity; peritoneal cavity compliance; intrathoracicpressure; bladder pressure; and/or rectal pressure.

In some embodiments, the adjusting step includes the step of adjustingfluid flow to achieve or maintain patient euvolumia; adjusting flow of atherapeutic agent (such as a chilled medium) to the patient; adjustingfluid flow to the patient through a peripheral venous catheter;adjusting fluid flow to the patient through a central venous catheter;adjusting fluid flow to the patient through an arterial catheter; and/oradjusting fluid flow to the patient's peritoneal cavity.

Yet another aspect of the invention provides a method of treatinghypotension in a patient. The method includes the following steps:monitoring a patient parameter (such as blood pressure or cardiacoutput) with a sensor to generate a sensor signal; providing the sensorsignal to a controller; and adjusting fluid flow to the patient based onthe sensor signal without removing fluid from the patient.

Still another aspect of the invention provides a method of treatingsepsis in a patient. The method includes the following steps: monitoringa patient parameter (such as blood pressure, central venous pressure, orcardiac output) with a sensor to generate a sensor signal; providing thesensor signal to a controller; and adjusting fluid flow to the patientbased on the sensor signal without removing fluid from the patient.Prevention of hypotension and/or hypovolemia is critical in the care ofpatients that have suffered severe hemorrhage or are septic. Thesepatients are very difficult to monitor and treat, taking significantnursing time and still resulting in suboptimal therapy due to theintermittent nature of the blood pressure, central venous pressureand/or cardiac output checks. The present invention, then, will optimizefluid flow to the patient while also freeing up the already over-taxednursing staff for other duties.

Yet another aspect of the invention provides a method of inducing andreversing therapeutic hypothermia in a patient. The method includes thesteps of: monitoring intracranial pressure to generate a sensor signal;providing the sensor signal to a controller; and adjusting rate ofhypothermia induction or rewarming based on intracranial pressure (suchas by adjusting fluid flow to the patient), or depth of hypothermia,based on the sensor signal.

In some embodiments of the invention, irrigation and/or lavage of bodilytissues, cavities or spaces (or other patient interventions) may beoptimized using a sensor or sensors to report electrical, chemical,acoustic, mechanical properties, pressure, temperature, pH or otherparameters surrounding the access device in order to automate andoptimize the irrigation/lavage.

Embodiments of the invention include a peritoneal catheter containingone or more sensors which may detect changes in electrocardiographmonitoring, electroencephalograph monitoring, pulse oximetry (eitherinternally or peripherally), peritoneal cavity compliance, intrathoracicpressure, intraperitoneal pressure, intraperitoneal pressure waveforms,bladder pressure, rectal pressure, cardiac output, cardiac strokevolume, cardiac rate, blood flow (e.g., in superior mesenteric, celiac,renal or other arteries), pressure in veins (particularly the inferiorvena cava or those that empty into the inferior vena cava, e.g., femoralvein), pressure in arteries (particularly those distal to the aorta,e.g., the femoral artery), total circulating blood volume, bloodoxygenation (e.g., in rectal mucosa, peripheral fingers and toes, etc.),whole body oxygen consumption, pH and/or arterial pO₂ (or any otherparameter that shows a measurable change with increased peritonealpressure) to ensure safety of automated or manual peritoneal lavage. Theinvention also includes methods of performing peritoneal lavage usingsuch devices.

Embodiments of the invention include an intravascular cathetercontaining one or more sensors which may detect changes inelectrocardiograph monitoring, electroencephalograph monitoring, pulseoximetry (either internally or peripherally), partial pressure of oxygenor CO₂, pH, temperature, blood pressure, central venous pressure,cardiac output, cardiac stroke volume, cardiac rate, blood flow (e.g.,in superior mesenteric, celiac, renal or other arteries), totalcirculating blood volume, pressure in veins (particularly those thatempty into the inferior vena cava, e.g., femoral vein), pressure inarteries (particularly those distal to the aorta, e.g., the femoralartery), blood oxygenation (e.g., in rectal mucosa, peripheral fingersand toes, etc.), whole body oxygen consumption, pH and/or arterial pO₂(or any other parameter that shows a measurable change withintravascular volume overload) to ensure safety of manual or automatedintravascular infusion. The invention also includes methods of usingsuch devices.

Other embodiments of the invention include control of the rate ofinfusion to minimize negative effects observed by the sensors. Theinvention may be used to induce and/or maintain hypothermia orhyperthermia; maximize hydration and/or intravascular volume in apatient receiving intravenous fluids (such as, e.g., post-operativepatients, post-hemorrhage patients, septic patients or other intensivecare patients).

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe claims that follow. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1 shows an automated infusion system in which infusion iscontrolled based on patient parameters sensed by multiple sensors.

FIG. 2 shows an automated infusion system in which a sensor controllinginfusion is separate from the infusion catheter.

FIG. 3 shows an automated infusion system in which sensing and infusionare performed with the same catheter.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1-3 show embodiments of the invention wherein intravenous fluiddelivery may be automated, or manually adjusted, based on feedback fromone or more sensors. In these embodiments, the infusion catheter mayhave a sensor to aid in insertion, but this is not necessary for thisinvention.

In one embodiment, the infusion catheter also is used to detect theparameters used to optimize therapy. FIG. 1 shows an infusion systemwith an infusion controller 10 operably connected to an intravenousinfusion catheter 12 via an infusion line 14. Infusion catheter 12 alsohas a sensor (not shown) attached to or associated with it to monitor apatient parameter. The sensor also communicates with controller 10either through line 14 or via some other communication channel. Suitablepatient parameters include electrocardiograph monitoring,electroencephalograph monitoring, pulse oximetry (either internally orperipherally), blood pressure, central venous pressure, cardiac output,cardiac stroke volume, cardiac rate, blood flow (e.g., in superiormesenteric, celiac, renal or other arteries), total circulating bloodvolume, pressure in veins (particularly those that empty into theinferior vena cava, e.g., femoral vein), pressure in arteries(particularly those distal to the aorta, e.g., the femoral artery),blood oxygenation (e.g., in rectal mucosa, peripheral fingers and toes,etc.), whole body oxygen consumption, pH, arterial pO₂, or any otherparameter that shows a measurable change with intravascular volumeoverload.

As shown in FIG. 1, additional catheters, here envisioned as aperipherally inserted central catheter (PICC) 16 and/or a peritonealcatheter 18, or additional sensors on infusion catheter 12 may be usedto monitor these or other parameters, and to optimize the infusion rateand achieve euvolemia without fluid overload or dehydration. Flow offluid and/or a fluid/solid mixture (e.g., an ice slurry) to catheters 16and/or 18 is controlled by controller 10 through lines 14, 15 and/or 17,respectively. The information from the sensors may then be transmittedto central controller 10, which integrates all of this information todetermine the flow of intravenous fluid through catheter 12 and/orcatheter 16 and flow of peritoneal fluid through catheter 18. Thisinformation may be used to achieve or maintain euvolemia (e.g., insepsis, hemorrhagic shock, etc.) or to maximize infusion for delivery ofa therapeutic agent, e.g., chilled fluid and/or solids to achievehypothermia. Alternatively, catheters 16 and 18 may be used with sensorsto obtain patent information, and fluid may be infused into the patientsolely through catheter 16 or catheter 18. In yet further embodiments,the depth of hypothermia and/or rate of hypothermia induction orrewarming may be tailored based on intracranial pressure sensor(s) (notshown) communicating with controller 10 via communication line 35. Thissystem and method may be used with any method of inducing hypothermia(e.g., cooling blankets, intravascular catheters, intravenous fluidinfusion, peritoneal lavage, etc.) so long as the change in temperature,particularly rewarming, is controlled at least in part by anintracranial pressure sensor.

The sensor or sensors, whether cables/catheters or percutaneousmonitoring technologies, and whether wired or wireless, may also beseparate from the infusion line so long as the information from thissensor or sensors is transferred to the control unit in order tooptimize fluid flow. Thus, as shown in FIG. 2, the patient parametersensor may be associated with PICC 24 and communicate with controllervia line 26, and infusion to the patient may be via line 22 and infusioncatheter 20, as controlled by controller 10. In some embodiments, ofcourse, sensing and infusion may be performed through a single catheter,such as PICC 30, and controlled by controller 10 through lines 32 and34, as shown in FIG. 3. In some embodiments, the infusion and monitoringdevice of the current invention may incorporate an access sensor, suchas that described in a commonly owned patent application, U.S. patentapplication Ser. No. 12/098,355, filed Apr. 4, 2008, titled “Device AndMethod For Safe Access To A Body Cavity”.

One example of such a device is a peripheral venous, central venous orarterial catheter that is capable of maintaining hydration withoutcausing fluid overload. The catheter may incorporate a sensor that maydetect central venous pressure, total circulating blood volume,peripheral venous pressure, cardiac output or osmolarity, and/or soluteconcentrations (e.g., chloride, sodium, etc.) in order to prevent fluidoverload. The sensor may also be external to the catheter, so long asthe output of said sensor is capable of controlling fluid flow throughthe catheter. In this embodiment, fluid flow is controlled by the outputof the sensor, which is integrated by a fluid flow control unit whichalters the rate of fluid flow based on this output. This embodiment mayallow the user to bolus large volumes of fluids or solids into thevascular space in order to rehydrate, induce hypothermia or reversehypothermia, or deliver a therapeutic agent or maintain blood pressurein sepsis.

In addition, this technology may provide a fully automated mechanism tooptimize fluid flow into the vessel without fluid overloading thepatient. Without this automated fluid delivery coupled to hemodynamicparameter monitoring, the patient is in danger of dehydration or fluidoverload from infusion of fluid into any body cavity. This technologymay also be applied to liquid or solid infusion into any body cavity orspace in so long as the fluid flow is automated based on feedback fromsensors within the body (possibly incorporated into the catheter itself)in order to optimize the volume of infusion.

This device and method of automating fluid flow based on hemodynamicsensor-based feedback may also be used to generate intravenoushypothermia. In its current state, IV hypothermia induction is limiteddue to concerns of fluid overload. If the hemodynamic parameters of thepatient can be measured and fluid flow directly or indirectly controlledbased on the output of these measurements, the volume of fluid can bemaximized while ensuring hemodynamic instability. In this embodiment,the sensor may be incorporated within the catheter, and fluid flow intothe vasculature may be tailored based on central venous pressure, totalcirculating blood volume, peripheral venous pressure, cardiac output orosmolarity, and/or solute concentrations (e.g., chloride, sodium, etc.)in order to prevent fluid overload.

In one embodiment, the fluid infusion catheter also may function as athermodilution cardiac output sensor such that the same fluid that isused to generate hypothermia may also be used to detect cardiac output.This information may then be relayed, either directly or indirectly,back to the fluid infusion controller to increase, decrease or even haltfluid flow based on these parameters. For example, if cardiac output islow and venous pressure or total circulating volume is low, the patienthas a low circulating volume and large volumes of fluid may be safelydelivered. If the cardiac output is normal, fluid may also be safelydelivered, but the cardiac output must be monitored to ensure that itdoes not begin to decrease (an indication of fluid overload). Bloodflow, as detected by, for instance, thermodilution may be determined ina peripheral vessel as well. These data, while relatively useless ontheir own in a clinical setting due to variability in peripheral bloodflow, may provide a baseline flow profile which may be rechecked overtime in order to compare flow within that individual vessel to thebaseline flow. Relatively improved flow may be correlated to improvedcardiac output, while a relative reduction in flow may be correlated tofluid overload.

This same system may be used to infuse normal fluids or hypothermicfluids to sepsis patients or patients requiring intensive maintenance oftheir hemodynamic status. Sepsis patients that are aggressivelymonitored do much better than those that are not. Aggressive monitoringis very nurse-intensive, however. A system that provides automatedoptimal fluid infusion based on sensed parameters to ensure that fluidoverload does not occur and that fluid infusion is not insufficientwould be an improvement over current methods of treating sepsispatients. The devices and methods for automated sensor-based input tocontrol fluid flow to a patient may be applicable to a wide range ofconditions and should not be limited to the narrow scope of theconditions requiring fluid infusion described here.

The logic controller of the present invention may provide improvedsafety by monitoring for any of the deleterious changes expected withexcess fluid flow, e.g., into the peritoneal cavity or vascular space.Examples of monitored parameters that may signal a warning orautomatically result in an adjustment to rate of fluidinfusion/extraction and/or fluid temperature include: electrocardiographmonitoring, electroencephalograph monitoring, pulse oximetry (eitherinternally or peripherally), peritoneal cavity compliance, intrathoracicpressure, intraperitoneal pressure, intraperitoneal pressure waveforms,bladder pressure, rectal pressure, cardiac output, cardiac strokevolume, cardiac rate, total circulating blood volume, blood flow (e.g.,in superior mesenteric, celiac, renal or other arteries), pressure inveins (particularly those that empty into the IVC, e.g., femoral vein),pressure in arteries (particularly those distal to the aorta, e.g., thefemoral artery), blood oxygenation (e.g., in rectal mucosa, peripheralfingers and toes, etc.), whole body oxygen consumption, pH and arterialpO₂ and any other parameter that shows a measurable change once theperitoneal or vascular spaces have been overloaded.

These parameters in particular have been found to change with increasesin peritoneal pressure, with significantly negative impact on eachparameter found at 40 mmHg. Thus, monitoring for these changes inconjunction with a peritoneal infusion catheter of the present inventionwill allow for even greater safety with peritoneal infusion. Theseparameters may be measured a variety of ways and the data transmittedeither wirelessly or via wires to the logic controller in order to alertthe healthcare provider or to automatically adjust the fluidflow/temperature in order to optimize both the flow of the peritonealfluid and patient safety.

What is claimed is:
 1. A method of inducing and reversing therapeutichypothermia in a patient, the method comprising: infusing a therapeuticagent from a catheter into a peritoneal cavity of the patient;monitoring a flow of the therapeutic agent through the catheter with asensor to generate a sensor signal; providing the sensor signal to acontroller; and adjusting infusion of the therapeutic agent from thecatheter to the peritoneal cavity with the controller based on thesensor signal to induce or reverse therapeutic hypothermia in thepatient without removing the therapeutic agent from the patient.
 2. Themethod of claim 1 wherein the therapeutic agent is infused into thepatient with a peritoneal catheter.
 3. The method of claim 1 wherein theinfusing step comprises a peritoneal lavage.
 4. The method of claim 1wherein the adjusting step is performed after the infusing step.
 5. Themethod of claim 1 wherein the therapeutic agent comprises a chilledfluid.
 6. The method of claim 1 wherein the sensor is positioned in thecatheter.
 7. The method of claim 1 wherein the sensor is separate fromthe catheter.
 8. A system configured to induce and reverse therapeutichypothermia or hyperthermia in a patient, the system comprising: a fluidsource having a therapeutic agent; a peritoneal catheter coupled to thefluid source, the peritoneal catheter configured to infuse thetherapeutic agent into a peritoneal cavity of the patient; a sensorconfigured to monitor a flow of the therapeutic agent through theperitoneal catheter to generate a sensor signal; and a controller incommunication with the sensor, the controller configured to adjustinfusion of the therapeutic agent from the peritoneal catheter into theperitoneal cavity based on the sensor signal to induce or reversetherapeutic hypothermia or hyperthermia in the patient without removingthe therapeutic agent from the patient.
 9. The system of claim 8 whereinthe sensor is disposed in the peritoneal catheter.
 10. The system ofclaim 8 wherein the sensor is separate from the peritoneal catheter. 11.The system of claim 8 wherein the controller is configured toautomatically adjust flow based on the sensor signal.
 12. A method ofinducing and reversing therapeutic hyperthermia in a patient, the methodcomprising: infusing a therapeutic agent from a catheter into aperitoneal cavity of the patient; monitoring a flow of the therapeuticagent through the catheter with a sensor to generate a sensor signal;providing the sensor signal to a controller; and adjusting infusion ofthe therapeutic agent from the catheter to the peritoneal cavity withthe controller based on the sensor signal to induce or reversetherapeutic hyperthermia in the patient without removing the therapeuticagent from the patient.
 13. The method of claim 12 wherein thetherapeutic agent is infused into the patient with a peritonealcatheter.
 14. The method of claim 12 wherein the infusing step comprisesa peritoneal lavage.
 15. The method of claim 12 wherein the adjustingstep is performed after the infusing step.